Supply Chain Planning for Today’s Uncertain World
Webinar on October 19 @ 11a-12p Eastern Supply Chain Planning for Today's Uncertain World Supply chain leaders in life sciences companies operate in a highly uncertain environment. Commercial and regulatory uncertainty is now compounded by the risk of supply disruptions and geopolitical barriers. For companies managing the complexity of [...]
Info Sheet: Extending Your Quality Capabilities
PDF Available > Focusing on patients and improved outcomes in a rapidly evolving environment requires maintaining appropriate controls to ensure quality and compliance from early in the lifecycle. A well-designed and stage-appropriate Quality Management System (QMS) is essential to facilitate the development and commercialization of these advanced treatments. Converge Consulting understands the complexities and [...]
Building a Roadmap for the CMC Portion of Your BLA Submission
Webinar on June 20 @ 2-3:30p Eastern Building a Roadmap for the CMC Portion of Your BLA Submission The New England chapter of the PDA is offering this webinar where Todd Applebaum of Converge Consulting and Vijay Chhajlani of ModeX Therapeutics will break down the elements of a strong [...]
What CMC and Finance Leaders Need to Know about Aligning CMC Programs with Finance
Webinar on May 26 @ 11a-12p ET What CMC and Finance Leaders Need to Know about Aligning CMC Programs with Finance CMC and Finance leaders often find themselves at odds with one another at many emerging companies. The CMC landscape is dynamic, often changing substantially. It can be difficult [...]
Advanced Planning: Developing Supply Risk Mitigation Strategies
Advanced Planning: Developing Supply Risk Mitigation Strategies Download the PDF Converge conducts a Manufacturing Supplier Risk Assessment and uses the results to build a Supplier Risk Management Plan. A commercial biopharmaceutical company was preparing for their second product launch when senior leadership acknowledged the need to prioritize the supply chain and manufacturing [...]
Implementing a Serialization Program Successfully on the First Try
An emerging specialty biopharmaceutical company was preparing for the U.S. launch of their first drug product. Building out their supply chain would involve implementing a serialization program to meet Drug Supply Chain Security Act (DSCSA) requirements. While Supply Chain team members had commercial launch experience, they were not as familiar with serialization. A successful [...]
2022 & Beyond: Serialization Requirements for Manufacturers
Life Sciences Supply Chain Working Group Webinar January 20, 2022 @ 12-1p ET 2022 & Beyond: Serialization Requirements for Manufacturers Read the Event Recap The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing [...]
Helping the Biotech Industry Bring Crucial Healthcare Innovations to Market
Helping the Biotech Industry Bring Crucial Healthcare Innovations to Market Todd Applebaum recently talked with Mission Matters about helping the biotech industry bring crucial healthcare innovations to market. Read the interview highlights on the Mission Matters website. Watch the full interview here:
Info Sheet: Clinical Supply Chain Services
PDF Available > Planning for, establishing, and managing the Clinical Supply Chain has its own set of challenges – regulatory requirements, clinical uncertainties, nuances of sourcing drug substance and API material, and logistical constraints including access to new points of patient care. Clinical supply leaders need to manage all of these while ensuring quality [...]